Humacyte, Inc. Q3 FY2024 earnings call

• FDA review of ATEV BLA in vascular trauma is ongoing; original PDUFA date was August 10, 2024, but extended; commercial team preparing for U.S. launch if approved; surgical sales executives trained and identifying key accounts. • Submitted NTAP application to CMS for fiscal year 2026 cycle. • V007 Phase 3 trial of ATEV in hemodialysis showed superior function and patency, highlighted subgroup analyses at Kidney Week. • ATEV received RMAT designation for PAD indication; IND cleared for PAD. • U.S. Patent Office allowed patent for BVP product candidate for type 1 diabetes; non-human primate studies support BVP potential. • Completed registered direct offering of approximately $30 million.

No revenue reported for the third quarter of 2024 or prior periods. Research and development, general and administrative, and other net expenses were detailed, but no product segment financial performance with revenue contribution applicable as there is no revenue.

• Confidence in approvability of ATEV in vascular trauma based on interactions with FDA. • Preparation for commercialization of ATEV if approved. • Continued advancement of other pipeline programs. • Cash position as of September 30, 2024, was $71.0 million, with subsequent net proceeds from stock sales.

• Delays in FDA review of ATEV BLA in vascular trauma. • Uncertainties in clinical trial outcomes and approvals. • Challenges in obtaining reimbursement through NTAP application. • Risks associated with pipeline program progress and regulatory hurdles.

Q: Ryan Zimmerman asked about the nature of FDA discussions post-PDUFA date delay, including facility inspections.

A: Laura Niklason stated that most substantive interaction was before PDUFA date; since then, occasional 'pinging' with CBER leadership, some paperwork requests but no substantive discussions.

Q: Josh Jennings inquired about the AV access indication, Fresenius agreement, and revision opportunities.

A: Laura Niklason discussed ongoing discussions with Fresenius, significance of catheter time reduction, and variable revision opportunities by practice.

Q: Kristen Kluska asked about AV access trial endpoints and community enthusiasm.

A: Laura Niklason explained co-primary endpoints of six and 12 months, SPA, and increasing enrollment in VO12 trial due to data dissemination.

Q: Bruce Jackson asked about supplemental BLA for AV access and CABG program.

A: Laura Niklason discussed independent pathway for AV access supplemental BLA, timing dependent on FDA review, and CABG program needing third animal model (sheep) study with FDA discussion.

Q: Vernon Bernardino asked about BVP program next steps.

A: Laura Niklason explained ongoing dosing studies in primates, evaluating islet sources, and need to prove BVP principle in large animals before first-in-man study.